131I-L19SIP Radioimmunotherapy Combined With Radiochemotherapy in Patients With Locally-advanced Non Small Cell Lung Cancer (NSCLC)
This study has been terminated.
Sponsor:
Philogen S.p.A.
Information provided by (Responsible Party):
Philogen S.p.A.
ClinicalTrials.gov Identifier:
NCT01124812
First received: May 12, 2010
Last updated: October 25, 2012
Last verified: June 2012
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Purpose
The aim of this feasibility study is to determine the therapeutic potential of the L19SIP antibody, labeled with the radionuclide 131I in combination with radiochemotherapy, for the treatment of patients with newly diagnosed, unresectable, locally-advanced NSCLC following the promising results with this agent in previous clinical studies.
The L19SIP antibody is a fully human antibody, capable of preferential localization around tumor blood vessels while sparing normal tissues. The formation of new blood vessels is a rare event in the adult (with the exception of the female reproductive tract), but it is a characteristic pathological feature for most types of aggressive cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer |
Other: 131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent Chemotherapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Non-randomized Study of 131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent Chemotherapy in Patients With Inoperable, Locally-advanced (Stage III) NSCLC |
Resource links provided by NLM:
Further study details as provided by Philogen S.p.A.:
Primary Outcome Measures:
- Uptake of 131I-L19SIP or 124I-L19SIP [ Time Frame: 2 days ] [ Designated as safety issue: No ]The selective uptake of 131I-L19SIP or 124I-L19SIP in lung lesions and dosimetric analysis
- Safety and tolerability of 131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent Chemotherapy [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]Safety will be assessed through physical examinations, vital signs, laboratory tests (including serum chemistries, hematology parameters) and the recording of adverse events. All results from these assessments will be coded using CTCAE v.3 and presented descriptively, indicating frequency and percentage of patients with adverse events, and abnormal laboratory tests. These results will be presented by related/unrelated and overall for the study.
- Dose Limiting Toxicities (DLTs) and Maximum Tolerated Dose/Recommended Dose (MTD/RD) for the combination treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Dose limiting toxicities and maximum tolerated dose/recommended dose for the combination treatment
Secondary Outcome Measures:
- Overall response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]Intrapulmonal, extra pulmonal and overall response rate
- Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 3 |
| Study Start Date: | May 2010 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 131I-L19SIP
131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent Chemotherapy: Treatment dose of 131I-L19SIP RIT is titrated in cohorts of 3 patients.
|
Other: 131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent Chemotherapy
Lung tumor irradiation with a total dosage of between 60-66 Gy, fractionated in combination with the following concurrent chemotherapy options:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed unresectable stage III NSCLC
- Males or females, age ≥ 18 years
- Measurable lung lesion defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria.
- ECOG performance status < 3
- Life expectancy of at least 12 weeks
- Patients eligible for concurrent radiochemotherapy (cisplatin/vinorelbine; 60-66 Gy EBRT) at the discretion of the clinical investigator
- Absolute neutrophil count > 1.5 x 109/L, hemoglobin > 9.0 g/dL and platelets > 100 x 109/L
- Total bilirubin ≤ 30 µmol/L (or ≤ 2.0 mg/Dl)
- ALT and AST ≤ 2.5 x the upper limit of normal (5.0 x ULN for patients with hepatic involvement with tumor
- Serum creatinine < 1.5 x ULN
- All toxic effects of prior therapy must have resolved to ≤ Grade 1 unless otherwise specified above
- Negative serum pregnancy test (for women of child-bearing potential only) at screening
Exclusion Criteria:
- Patients with metastatic disease
- Patients amenable for surgical resection of lung tumor lesions
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (TA, Tis & Ti) or any cancer curatively treated < 5 years prior to study entry
- History of HIV infection or infectious hepatitis B or C
- Presence of active infections (e.g. requiring antibimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
- Inadequately controlled cardiac arrhythmias including atrial fibrillation
- Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria)
- Uncontrolled hypertension
- Ischemic peripheral vascular disease (Grade IIb-IV)
- History of an acute cardiac event such as myocardial infarction, instable angina pectoris during the last 12 months
- Severe diabetic retinopathy
- Active autoimmune disease
- History of organ allograft or stem cell transplantation
- Recovery from major trauma including surgery within 4 weeks prior to administration of study treatment
- Breast feeding female
- Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before administration of study treatment
- Growth factors or immunomodulatory agents within 7 days of the administration of study treatment (131I-L19SIP application).
- Hyperthyroidism or autonomous thyroid nodule
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124812
Locations
| Italy | |
| University Hospital Pisa | |
| Pisa, Tuscany, Italy, 56126 | |
| Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Meldola (Fc) | |
| Meldola, Italy | |
Sponsors and Collaborators
Philogen S.p.A.
Investigators
| Principal Investigator: | Giovanni Paganelli, Dr | IRST - ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI - MELDOLA (FC) |
More Information
No publications provided
| Responsible Party: | Philogen S.p.A. |
| ClinicalTrials.gov Identifier: | NCT01124812 History of Changes |
| Other Study ID Numbers: | PH-L19SIPI131-04/09, 2009-017072-24 |
| Study First Received: | May 12, 2010 |
| Last Updated: | October 25, 2012 |
| Health Authority: | Italy: National Institut of Health (Istituto Superiore di Sanità) Italy: Ethics Committee |
Keywords provided by Philogen S.p.A.:
|
I131 L19 antibody monoclonal NSCLC |
lung tumor targeting radioimmunotherapy Patients with newly diagnosed inoperable, locally-advanced (stage III) NSCLC |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013